mstockstill on PROD1PC66 with NOTICES


Federal Register / Vol. 74, No. 55 / Tuesday, March 24, 2009 / Notices 12363 

directly to the OS OMB Desk Officer all 

comments must be faxed to OMB at 

202–395–6974. 

Proposed Project: Institutional Review 

Board/Independent Ethics Committee 

Forms Modification–OMB No. 0990– 

0279—Office for Human Research 

Protections. 

Abstract: The Office for Human 

Research Protections (OHRP) is 

requesting a modification to the current 

Institutional Review Board (IRB) 

Independent Ethics Committee (IEC) 

Registration Form designed to provide a 

simplified procedure for institutions 

engaged in Department of Health and 

Human Services (HHS) conducted or 

supported research to satisfy the 

assurance requirements of Section 

491(a) of the Public Health Service Act 

and HHS regulations for the protection 

of human subjects at 45 CFR 46.103. 

The form is being modified to be 

consistent with IRB-Registration 

requirements that are included in the 

Office for Human Research Protections 

(OHRP) and the Food and Drug 

Administration (FDA) final rules on IRB 

registration requirements. Respondents 

for this information collection are 

institutions or organizations operating 

IRBs designated by an institution under 

ESTIMATED ANNUALIZED BURDEN TABLE 

an assurance of compliance approved 

for federalwide use by OHRP under 45 

CFR 46.103(a) and that review human 

subjects research conducted or 

supported by HHS, or, in the case of 

FDA’s regulation, each IRB in the 

United States that reviews clinical 

investigations regulated by FDA under 

sections 505(i) or 520(g) of the Federal 

Food, Drug and Cosmetic Act; and each 

IRB in the United States that reviews 

clinical investigations that are intended 

to support applications for research or 

marketing permits for FDA-regulated 

products. 

Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

hours 

IRB Registration 0990–0279 ........................................................................... 

FDA–IRB .......................................................................................................... 

6,000 

1,000 

2 

2 

1 

1 

12,000 

2,000 

Total .......................................................................................................... ........................ ........................ ........................ 14,000 

Terry Nicolosi, 

Office of the Secretary, Paperwork Reduction 

Act Reports Clearance Officer. 

[FR Doc. E9–6429 Filed 3–23–09; 8:45 am] 

BILLING CODE 4150–36–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institute for Occupational 

Safety and Health; Decision To 

Evaluate a Petition To Designate a 

Class of Employees for the Baker 

Perkins Atomic Weapons Employer 

Facility in Saginaw, MI, To Be Included 

in the Special Exposure Cohort 

AGENCY: National Institute for 

Occupational Safety and Health 

(NIOSH), Department of Health and 

Human Services (HHS). 

ACTION: Notice. 

SUMMARY: HHS gives notice as required 

by 42 CFR 83.12(e) of a decision to 

evaluate a petition to designate a class 

of employees for the Baker Perkins 

Atomic Weapons Employer facility in 

Saginaw, Michigan, to be included in 

the Special Exposure Cohort under the 

Energy Employees Occupational Illness 

Compensation Program Act of 2000. The 

initial proposed definition for the class 

being evaluated, subject to revision as 

warranted by the evaluation, is as 

follows: 

Facility: Baker Perkins Atomic 

Weapons Employer. 

Location: Saginaw, Michigan. 

Job Titles and/or Job Duties: All 

employees. 

Period of Employment: May 14, 1956 

through July 12, 1968. 

FOR FURTHER INFORMATION CONTACT: 

Larry Elliott, Director, Office of 

Compensation Analysis and Support, 

National Institute for Occupational 

Safety and Health (NIOSH), 4676 

Columbia Parkway, MS C–46, 

Cincinnati, OH 45226, Telephone 513– 

533–6800 (this is not a toll-free 

number). Information requests can also 

be submitted by e-mail to 

OCAS@CDC.GOV. 

Christine M. Branche, 

Acting Director, National Institute for 

Occupational Safety and Health. 

[FR Doc. E9–6368 Filed 3–23–09; 8:45 am] 

BILLING CODE 4163–19–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institute for Occupational 

Safety and Health; Decision To 

Evaluate a Petition To Designate a 

Class of Employees for the ElectroMetallurgical Corporation Facility, 

Niagara Falls, NY, To Be Included in 

the Special Exposure Cohort 

AGENCY: National Institute for 

Occupational Safety and Health 

(NIOSH), Department of Health and 

Human Services (HHS). 

ACTION: Notice. 

SUMMARY: HHS gives notice as required 

by 42 CFR 83.12(e) of a decision to 

evaluate a petition to designate a class 

of employees for the ElectroMetallurgical Corporation facility, 

Niagara Falls, New York, to be included 

in the Special Exposure Cohort under 

the Energy Employees Occupational 

Illness Compensation Program Act of 

2000. The initial proposed definition for 

the class being evaluated, subject to 

revision as warranted by the evaluation, 

is as follows: 

Facility: Electro-Metallurgical 

Corporation. 

Location: Niagara Falls, New York. 

Job Titles and/or Job Duties: All 

employees. 

Period of Employment: August 13, 

1942 through December 31, 1953. 

FOR FURTHER INFORMATION CONTACT: 

Larry Elliott, Director, Office of 

Compensation Analysis and Support, 

National Institute for Occupational 

Safety and Health (NIOSH), 4676 

Columbia Parkway, MS C–46, 

Cincinnati, OH 45226, Telephone 513– 

533–6800 (this is not a toll-free 

number). Information requests can also 

be submitted by e-mail to 

OCAS@CDC.GOV. 

Christine M. Branche, 

Acting Director, National Institute for 

Occupational Safety and Health. 

[FR Doc. E9–6380 Filed 3–23–09; 8:45 am] 

BILLING CODE 4163–19–P